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An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.
On Nov. 23, 2020, AstraZeneca announced its COVID-19 vaccine candidate, AZD1222, showed positive high-level results in interim analyses of clinical trials in the United Kingdom and Brazil.
According to a company press release, the vaccine was highly effective in preventing COVID-19, with no hospitalizations or severe cases reported in participants receiving the vaccine. An independent data safety monitoring board determined that the clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from the disease for 14 days or more after receiving two doses of the vaccine.
Additionally, one dosing of the vaccine showed efficacy of 90% when given as a half dose, followed by a full dose at least one month apart, and another dosing showed 62% efficacy when given as two full doses at least one month apart, the press release said. This resulted in an efficacy of 70%.
“These findings show that we have an effective vaccine that willsavemanylives,” said Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford, in the press release. “Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”
“Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency,” added Pascal Soriot, CEO, AstraZeneca, in the press release. “Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable, and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”
AstraZeneca will now seek regulatory submission of the data to authorities around the world for conditional or early approval. It will also request an Emergency Use Listing from the World Health Organization for vaccine availability in low-income countries.